Actively Recruiting
A Single-dose, Open-label Phase I Trial Comparing Pharmacokinetics, Safety, and Pharmacodynamics of HRS-1301 Tablets in Subjects With Renal Insufficiency and Healthy Subjects
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-05-13
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how the body processes HRS-1301 tablets in adults with different levels of kidney function compared to healthy adults. The goal is to understand how kidney impairment affects the medicine's behavior in the body and to develop dosing recommendations for patients with kidney problems. This is a phase 1 clinical trial sponsored by Shandong Suncadia Medicine Co., Ltd. Participants will receive a single oral dose of HRS-1301 tablets. The study includes groups with mild, moderate, and severe kidney impairment as well as healthy subjects. The trial is open-label, meaning both researchers and participants know the treatment being given. The treatment period lasts up to 8 days post-dose to observe the drug's effects. During the study, participants will undergo blood and urine tests to measure drug levels and how the body clears the medicine over time. Researchers will track maximum drug concentration, exposure over time, elimination half-life, and safety through adverse event monitoring. These assessments occur from dosing up to 8 days later. The total participation duration varies but includes close monitoring of drug behavior and safety.
CONDITIONS
Brief Title
A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign informed consent and understand the trial process and possible reactions
- Male or female aged 18 to 65 years
- Body mass index between 18 and 30 kg/m2
- Weight at least 50 kg for males or 45 kg for females
- Glomerular filtration rate (GFR) matching mild (60-89 mL/min), moderate (30-59 mL/min), or severe (15-29 mL/min) renal impairment
You will not qualify if you...
- History of allergies such as asthma, urticaria, eczema, or allergies to any drug or food
- Cardiogenic shock, severe heart conduction issues, heart failure (NYHA III-IV), or certain arrhythmias
- Malignant tumors or history of tumors within 5 years (except certain skin cancers)
- History of gastric or intestinal surgery affecting drug absorption
- Severe trauma or major surgery within 3 months or planned surgery during the trial
- Participation in other clinical trials within 3 months or within five half-lives of another drug
- Blood donation of 400 mL or more within 4 weeks, severe blood loss, or blood transfusion within 8 weeks
- Receipt of live vaccines within 4 weeks before or planned during the trial
- Difficulty with blood collection or history of fainting at needles
- Renal replacement therapy within 3 months prior or during the trial
- Poorly controlled underlying diseases causing kidney disease, such as high HbA1c over 10% or very high blood pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 days
Participants receive a single dose of the study drug HRS-1301 tablet and are monitored for pharmacokinetics, safety, and pharmacodynamics.
Multiple visits for assessments over 8 days after dosing
Trial Site Locations
Total: 1 location
1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
Research Team
Y
Ying Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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